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New Study Investigates Pegasys(R) and Copegus(R) for the Treatment of Chronic Hepatitis C in African Americans

- Important news for African Americans - Historically one of the most difficult to treat hepatitis C patient populations -

BOSTON, Oct. 27 /PRNewswire/ -- New data on response to treatment in African Americans with chronic hepatitis C using the combination of Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin, USP) were reported on Sunday, October 26, at the American Association for the Study of Liver Diseases (AASLD) 54th annual meeting in Boston, MA. This is the largest prospective study reporting the efficacy, safety and tolerability of pegylated interferon and ribavirin combination therapy in non-Hispanic African Americans compared to Caucasians, all of whom had genotype 1 hepatitis C, the most difficult to treat.

In this study, the combination therapy of Pegasys and Copegus yielded a 26 percent sustained virological response (SVR) in African American patients. The sustained virological response rate for Caucasian patients in the study was 39 percent. Sustained virological response refers to a patient's continued undetectable serum hepatitis C RNA levels 24 weeks after finishing a course of treatment.

"These data are especially important because African Americans have historically been underrepresented in clinical trials for hepatitis C," said Juan Carlos Lopez-Talavera, MD, PhD, Medical Director, Roche Laboratories, Inc. "With these data, we can better understand how best to manage this large and difficult to treat patient population."

Pegasys, a pegylated alpha interferon, and Copegus, an oral antiviral, were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.

Study Design

The study was conducted at eleven sites in the United States and included 78 African American patients and 28 Caucasian patients. All patients were interferon-naive with chronic hepatitis C genotype 1 and elevated ALT levels. Patients received 180 mcg subcutaneously of Pegasys, once weekly, along with either 1000 or 1200 mg/day of Copegus, depending on their weight, for 48 weeks, with 24 weeks of treatment-free follow-up. Early virological response (EVR) was assessed at 12 weeks of therapy and SVR at week 72.

This trial included a relatively small cohort of patients receiving treatment. Studies with larger patient populations are currently underway to confirm the findings from this study. Conclusions should not be drawn in non- African American populations because of the small numbers (n=28) of non- African Americans in the study.

Adverse Events

Adverse events were similar to those seen in Pegasys and Copegus registration trials. Incidence rates for AEs among the Caucasian patient and African American patient groups included: fatigue (71 percent vs. 60 percent), headache (82 percent vs. 54 percent), insomnia (50 percent vs. 27 percent), and nausea (54 vs. 23 percent). Five percent of African American patients and fourteen percent of Caucasian patients withdrew prematurely due to adverse events or laboratory abnormalities. African Americans had lower baseline absolute neutrophil counts compared to Caucasian patients. Dose modifications of Pegasys (withheld or reduced) occurred among 46 percent of African Americans and 29 percent of Caucasians; the most common cause was neutropenia (37 percent among African Americans and 18 percent among Caucasians).

The Impact of Hepatitis C on African Americans

African Americans have the highest prevalence rates for hepatitis C among all racial and ethnic groups in the United States, but have historically been underrepresented in clinical trials examining the treatment of the disease. Almost all African Americans with hepatitis C are infected with genotype 1 (91 percent compared to 67 percent of Caucasians with hepatitis C). Hepatitis C is a blood-borne virus that chronically infects an estimated 2.7 million Americans. It can cause progressive liver injury and lead to fibrosis and eventually cirrhosis.


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